Study of Rivoglitazone in Type 2 Diabetes Mellitus

• Sponsor: Daiichi Sankyo, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00484198
• Collaborator: (none)
• Enrollment: 1,912
• Locations: 184
• Arms: 4
• Actual Duration (Months): 21.7
• Patients Per Site: 10.4
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This is a 26-week study in subjects with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. The total duration of a subject's participation will be approximately 30 weeks, including a 2-week placebo run-in period, a 26-week double-blind treatment period, and a 2-week post-treatment follow-up period.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: Pioglitazone; Drug: Placebo; Drug: Rivoglitazone; Drug: Rivoglitazone	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1912 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo and Active Comparator-Controlled, Parallel-Group Study of the Efficacy and Safety of Rivoglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
• Actual Study Start Date: Apr 23, 2007
• Actual Primary Completion Date: Feb 12, 2009
• Actual Study Completion Date: Feb 12, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1	Drug: Placebo; Rivoglitazone-matching placebo administered as a tablet orally, once daily or a pioglitazone-matching placebo administered as an over-encapsulated tablet orally, once daily capsule
Experimental: 2 Rivoglitazone 1.0 mg	Drug: Rivoglitazone; 1.0 mg tablet administered orally, once daily
Experimental: 3 Rivoglitazone 1.5 mg	Drug: Rivoglitazone; 1.5 mg tablet administered orally, once daily
Active Comparator: 4 Pioglitazone 45 mg	Drug: Pioglitazone; 45 mg over-encapsulated tablet administered orally, once daily; Other Names: Actos

Outcome Measures

Primary Outcome Measures

1. Hemoglobin A1c at Baseline and Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [Baseline up to week 26 post-dose]

   Percentage of hemoglobin A1c (HbA1c) levels are reported.

2. Change in Hemoglobin A1c From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [Baseline up to 26 weeks post-dose]

   Percent change in hemoglobin (HbA1c) levels are reported. Greater (negative) percent change indicates improvement.

Secondary Outcome Measures

1. Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [Baseline up to week 26 post-dose]

   Normal fasting plasma glucose (FPG) levels are being reported. Normal FPG levels range from 70-110 mg/dL. Lower FPG values indicates better clinical outcome, ie. improvement in FPG.

2. Change in Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [Baseline up to 26 weeks post-dose]

   The change in normal fasting plasma glucose (FPG) levels are being reported. A greater (negative) change from baseline indicates an improvement in FPG.

3. Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [Baseline up to week 26 post-dose]

   Homeostasis Model Assessment index for Insulin Resistance (HOMA-IR) was calculated as: (fasting insulin concentration [μU/mL] x fasting glucose concentration [mmol/L])/22.5 Low HOMA-IR scores indicate high insulin sensitivity, whereas high HOMA-IR scores indicate low insulin sensitivity (insulin resistance). A normal HOMA-IR score is <2.60, HOMA-IR scores 2.60-3.80 are considered "borderline high", and HOMA-IR scores >3.80 are considered "high" and have correlations of insulin resistance. High HOMA-IR scores indicate worse outcome.

4. Change in Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [Baseline up to 26 weeks post-dose]

   The change in the Homeostasis Model Assessment index for Insulin Resistance (HOMA-IR) was calculated as: (fasting insulin concentration [μU/mL] x fasting glucose concentration [mmol/L])/22.5 Low HOMA-IR scores indicate high insulin sensitivity, whereas high HOMA-IR scores indicate low insulin sensitivity (insulin resistance). A normal HOMA-IR score is <2.60, HOMA-IR scores 2.60-3.80 are considered "borderline high", and HOMA-IR scores >3.80 are considered "high" and have correlations of insulin resistance. A negative HOMA-IR score indicates an improvement in insulin sensitivity.

5. Total Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [Baseline up to week 26 post-dose]

   Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol.

6. Percent Change in Total Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [Baseline up to 26 weeks post-dose]

   Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol. Higher percent change in total cholesterol indicates better outcome, ie. improvement.

7. Total Triglycerides At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [Baseline up to Week 26 post-dose]

   Total Triglycerides (TG) is a measure of the total amount of triglycerides in the blood. The equation to calculate total triglycerides is: (total cholesterol-Low-density Lipoprotein cholesterol (LDL- C) - High-density lipoprotein cholesterol (HDL- C)) x 5 = Total Triglycerides. Normal triglyceride levels are below 150 mg/dL.

8. Percent Change in Total Triglycerides From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [Baseline up to 26 weeks post-dose]

   Total Triglycerides (TG) is a measure of the total amount of triglycerides in the blood. The equation to calculate total triglycerides is: (total cholesterol-Low-density Lipoprotein cholesterol (LDL- C) - High-density lipoprotein cholesterol (HDL- C)) x 5 = Total Triglycerides. A negative change means better outcome, ie. improvement.

9. Low-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [Baseline up to Week 26 post-dose]

   Low-density lipoprotein cholesterol (LDL-C), "bad" cholesterol, is a measure of the total amount of low-density lipoprotein cholesterol in the blood. Normal LDL levels are <100 mg/dL.

10. Percent Change in Low-Density Lipoprotein Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [Baseline up to 26 weeks post-dose]

    Low-density lipoprotein cholesterol (LDL-C), "bad" cholesterol, is a measure of the total amount of low-density lipoprotein cholesterol in the blood. A higher percent change indicates improvement.

11. High-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [Baseline to Week 26 post-dose]

    High-density lipoprotein cholesterol (HDL-C), "good" cholesterol, is a measure of the total amount of high-density lipoprotein cholesterol in the blood. Normal HDL levels are >40 mg/dL.

12. Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [Baseline to 26 weeks post-dose]

    High-density lipoprotein cholesterol (HDL-C), "good" cholesterol, is a measure of the total amount of high-density lipoprotein cholesterol in the blood. A higher percent change indicates improvement.

13. Apolipoprotein A-I At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [Baseline to Week 26 post-dose]

    Apolipoprotein (Apo) A-I levels, a measure of the total amount of Apolipoprotein (Apo) A-I in the blood, are being reported. Normal Apo A-1 levels range from 120-140 mg/dL.

14. Percent Change in Apolipoprotein A-I From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [Baseline up to 26 weeks post-dose]

    Apolipoprotein (Apo) A-I is a measure of the total amount of Apolipoprotein (Apo) A-I in the blood. Decreased ApoA-1 levels are associated with poor clinical outcome. A lower percent change in ApoA-1 levels indicates an improvement in clinical outcome.

15. Apolipoprotein B At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [Baseline to Week 26 post-dose]

    Apolipoprotein (Apo) B, a measure of the total amount of Apo B in the blood, is being reported. Normal Apo B levels are <100 mg/dL.

16. Percent Change in Apolipoprotein B From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [Baseline up to 26 weeks post-dose]

    Apolipoprotein (Apo) B, a measure of the total amount of Apo B in the blood, is being reported. A greater (negative) percent change in ApoB levels indicated an improvement in clinical outcome.

17. Hemoglobin A1c at Baseline and Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [Baseline up to Week 52 post-dose]

    Percentage of hemoglobin A1c (HbA1c) levels are reported.

18. Change in Hemoglobin A1c From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [Baseline up to 52 weeks post-dose]

    Change in hemoglobin (HbA1c) levels are reported. Greater (negative) percent change indicates improvement.

19. Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [Baseline up to Week 52 post-dose]

    Normal fasting plasma glucose (FPG) levels are being reported. Normal FPG levels range from 70-110 mg/dL. Lower FPG values indicates better clinical outcome, ie. improvement in FPG.

20. Change in Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [Baseline up to 52 weeks post-dose]

    The change in normal fasting plasma glucose (FPG) levels are being reported. A greater (negative) change from baseline indicates an improvement in FPG.

21. Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [Week -2 up to Week 52 post-dose]

    Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of double-blind study medication, and ongoing AEs that started prior to the first dose of double-blind study medication and increased in severity on or after the first dose of double-blind study medication.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of type 2 diabetes

• Male or female at least 18 years of age

• Hemoglobin A1C > 7% and less or equal to 8.5%

• Non-fasting C-peptide > 0.5 ng/mL

• Current monotherapy treatment with stable dose of approved non-Thiazolidinedione (TZD) antihyperglycemic medication for greater or equal to 3 months prior to screening or

• Untreated with any antihyperglycemic agent during 2 months prior to screening

Exclusion Criteria:

• History of type 1 diabetes or ketoacidosis

• History of long-term therapy with insulin

• Body Mass Index (BMI) > 45 kg/m^2

• Known history of Congestive Heart Failure (CHF)

• Impaired hepatic function

• History of prior treatment failure with, or intolerance of, a TZD

• Contraindication to treatment with pioglitazone

• Treatment with fibrates

• If untreated with oral antihyperglycemic, considered to have failed diet and exercise modification as the sole treatment for type 2 diabetes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Anniston	Alabama	United States
2		Birmingham	Alabama	United States
3		Hoover	Alabama	United States
4		Muscle Shoals	Alabama	United States
5		Hot Springs	Arkansas	United States
6		Jonesboro	Arkansas	United States
7		Little Rock	Arkansas	United States
8		Buena Park	California	United States
9		Garden Grove	California	United States
10		Huntington Park	California	United States
11		Los Angeles	California	United States
12		Paramount	California	United States
13		Sacramento	California	United States
14		San Diego	California	United States
15		Walnut Creek	California	United States
16		West Covina	California	United States
17		West Hills	California	United States
18		Denver	Colorado	United States
19		Delray Beach	Florida	United States
20		Jacksonville	Florida	United States
21		Merritt Island	Florida	United States
22		Miami	Florida	United States
23		Pembroke Pines	Florida	United States
24		Tampa	Florida	United States
25		Honolulu	Hawaii	United States
26		Boise	Idaho	United States
27		Chicago	Illinois	United States
28		Evansville	Indiana	United States
29		Indianapolis	Indiana	United States
30		Wichita	Kansas	United States
31		Madisonville	Kentucky	United States
32		New Orleans	Louisiana	United States
33		Slidell	Louisiana	United States
34		Springfield	Massachusetts	United States
35		Portage	Michigan	United States
36		Southfield	Michigan	United States
37		Saint Louis	Missouri	United States
38		Voorhees	New Jersey	United States
39		Syracuse	New York	United States
40		Morehead City	North Carolina	United States
41		Salisbury	North Carolina	United States
42		Statesville	North Carolina	United States
43		Winston-Salem	North Carolina	United States
44		Cincinnati	Ohio	United States
45		Cleveland	Ohio	United States
46		Delaware	Ohio	United States
47		Lyndhurst	Ohio	United States
48		Marion	Ohio	United States
49		Oklahoma City	Oklahoma	United States
50		Tulsa	Oklahoma	United States
51		Portland	Oregon	United States
52		Beaver	Pennsylvania	United States
53		Philadelphia	Pennsylvania	United States
54		Charleston	South Carolina	United States
55		Columbia	South Carolina	United States
56		Cleveland	Tennessee	United States
57		Kingsport	Tennessee	United States
58		New Tazewell	Tennessee	United States
59		Carrollton	Texas	United States
60		Conroe	Texas	United States
61		Corpus Christi	Texas	United States
62		Dallas	Texas	United States
63		El Paso	Texas	United States
64		Garland	Texas	United States
65		Irving	Texas	United States
66		Midland	Texas	United States
67		San Antonio	Texas	United States
68		Richmond	Virginia	United States
69		Olympia	Washington	United States
70		Milwaukee	Wisconsin	United States
71		Loma Verde	Buenos Aires	Argentina
72		Zarate	Buenos Aires	Argentina
73		San Vicente	Cordoba	Argentina
74		Feldkirch		Austria
75		Graz		Austria
76		Wien		Austria
77		Santiago	Providencia	Chile
78		Santiago		Chile
79		Temuco		Chile
80		Horní Město		Czechia
81		Karlovy Vary		Czechia
82		Prague		Czechia
83		Praha		Czechia
84		Usti nad Labem		Czechia
85		Vysoký Les		Czechia
86		Zlin		Czechia
87		Znojmo		Czechia
88		Aschaffenburg		Germany
89		Augsburg		Germany
90		Bad Oeynhausen		Germany
91		Berlin		Germany
92		Bosenheim		Germany
93		Dortmund		Germany
94		Dresden		Germany
95		Friedrichsthal		Germany
96		Giessen		Germany
97		Halle		Germany
98		Hamburg		Germany
99		Kippenheim		Germany
100		Mainz		Germany
101		Rehlingen		Germany
102		Riesa		Germany
103		Saarbrucken		Germany
104		Saarlouis		Germany
105		Siegen		Germany
106		Wiesbaden		Germany
107		Balatonfured		Hungary
108		Bekescsaba		Hungary
109		Budapest		Hungary
110		Debrecen		Hungary
111		Eger		Hungary
112		Gyula		Hungary
113		Kaposvar		Hungary
114		Szentes		Hungary
115		Hyderabad	Andhra Pradesh	India
116		Vijayawada	Andhra Pradesh	India
117		Visakhapatnam	Andhra Pradesh	India
118		Vasanth Nagar	Bangalore	India
119		Mylapore	Chennai	India
120		Shastri Nagar	Ghaziabad	India
121		Ahmedabad	Gujarat	India
122		Gandhinagar	Gujarat	India
123		Karnal	Haryana	India
124		Sarwa C.	Jaipur	India
125		Bangalore	Karnataka	India
126		Belgaum	Karnataka	India
127		Mangalore	Karnataka	India
128		Kochi	Kerala	India
129		Indore	Madhya Pradesh	India
130		Mumbai	Maharashtra	India
131		Dhantoli	Nagpur	India
132		Ramdaspeth	Nagpur	India
133		Jaipur	Rajasthan	India
134		Coimbatore	Tamil Nadu	India
135		Aligarh	Uttar Pradesh	India
136		Daugavpils		Latvia
137		Kuldiga		Latvia
138		Liepaja		Latvia
139		Riga		Latvia
140		Cuernavaca	Morelos	Mexico
141		Monterrey	Nuevo Leon	Mexico
142		Metepec	Toluca	Mexico
143		Merida	Yucatan	Mexico
144		Aguascalientes		Mexico
145		Durango		Mexico
146		Puebla		Mexico
147		La Victoria	Lima	Peru
148		Magdalena del Mar	Lima	Peru
149		San Juan de Miraflores	Lima	Peru
150		San Martin de Porres	Lima	Peru
151		Monterrico	Sucro Lima	Peru
152		Lima		Peru
153		Rio Piedras		Puerto Rico
154		San Juan		Puerto Rico
155		Villa Fontana		Puerto Rico	00983
156		Arad		Romania
157		Brasov		Romania
158		Bucharest		Romania
159		Satu Mare		Romania
160		Targu Mures		Romania
161		Belgrade		Serbia
162		Kragujevac		Serbia
163		Nis		Serbia
164		Subotica		Serbia
165		Zemun		Serbia
166		Bratislava		Slovakia
167		Lucenec		Slovakia
168		Moldava nad Bodvou		Slovakia
169		Nove Mesto nad Vahom		Slovakia
170		Považská Bystrica		Slovakia
171		Zilina		Slovakia
172		Johannesburg		South Africa
173		Port Elizabeth		South Africa
174		Dnipropetrovs'k		Ukraine
175		Kharkov		Ukraine
176		Kiev		Ukraine
177		Lviv		Ukraine
178		Simferopol		Ukraine
179		Edmonton	London	United Kingdom
180		Sunbury	Middlesex	United Kingdom
181		Addlestone	Surrey	United Kingdom
182		Wakefield	West Yorks	United Kingdom
183		Swindon	Wiltshire	United Kingdom
184		Chippenham		United Kingdom

Sponsors and Collaborators

• Daiichi Sankyo, Inc.

Investigators

• Study Director: Global Clinical Leader, Daiichi Sankyo, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daiichi Sankyo, Inc.
• ClinicalTrials.gov Identifier: NCT00484198
• Other Study ID Numbers: CS0011-A-U301; 2006-005047-28
• First Posted: Jun 8, 2007
• Last Update Posted: Jul 27, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Daiichi Sankyo, Inc.: Type 2 Diabetes Mellitus
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Pioglitazone

Study Results

Participant Flow

Recruitment Details	A total of 1,912 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study at 254 sites in Africa, Asia, Europe, North America, and South America.
Pre-assignment Detail	During the 2-week stabilization/washout, single-blind, placebo run-in period, participants were to discontinue any previous therapy with oral anti-hyperglycemic agents and were to self-administer single-blind, double-dummy, placebo medication consisting of over-encapsulated pioglitazone-matching placebo tablets and rivoglitazone-matching placebo tablets once daily.

Arm/Group Title	Placebo	Rivoglitazone 1.0 mg	Rivoglitazone 1.5 mg	Pioglitazone 45 mg
Arm/Group Description	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks. Extension Period: Participants who received Placebo in the base study received Pioglitazone 45 mg once daily for 26-week cycles (Cycle 1 and 2) instead in the extension period.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks. Extension Period: Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 week cycles (Cycle 1 and 2).	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks. Extension Period: Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks cycles (Cycle 1 and 2).	Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks. Extension Period: Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 week cycles (Cycle 1 and Cycle 2).
Period Title: Overall Study
STARTED	137	274	750	751
COMPLETED	96	208	599	579
NOT COMPLETED	41	66	151	172

Baseline Characteristics

Arm/Group Title	Placebo	Rivoglitazone 1.0 mg	Rivoglitazone 1.5 mg	Pioglitazone 45 mg	Total
Arm/Group Description	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.	Total of all reporting groups
Overall Participants	137	274	750	751	1912
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.4 (12.32)	55.0 (10.51)	55.1 (10.59)	55.0 (10.84)	55.0 (10.80)
Sex: Female, Male (Count of Participants)
Female	70 51.1%	142 51.8%	368 49.1%	353 47%	933 48.8%
Male	67 48.9%	132 48.2%	382 50.9%	398 53%	979 51.2%
Race/Ethnicity, Customized (Count of Participants)
Hispanic or Latino	33 24.1%	59 21.5%	171 22.8%	151 20.1%	414 21.7%
Not Hispanic or Latino	104 75.9%	215 78.5%	579 77.2%	600 79.9%	1498 78.3%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	2 1.5%	3 1.1%	11 1.5%	1 0.1%	17 0.9%
Asian	42 30.7%	89 32.5%	245 32.7%	243 32.4%	619 32.4%
Black or African American	2 1.5%	17 6.2%	33 4.4%	35 4.7%	87 4.6%
White	80 58.4%	147 53.6%	406 54.1%	414 55.1%	1047 54.8%
Other	11 8%	18 6.6%	55 7.3%	58 7.7%	142 7.4%

Outcome Measures

1. Primary Outcome

Title	Hemoglobin A1c at Baseline and Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Description	Percentage of hemoglobin A1c (HbA1c) levels are reported.
Time Frame	Baseline up to week 26 post-dose

Outcome Measure Data

Analysis Population Description

Hemoglobin A1c (HbA1c) levels were assessed using the Full Analysis Set.

Arm/Group Title	Placebo	Rivoglitazone 1.0 mg	Rivoglitazone 1.5mg	Pioglitazone 45 mg
Arm/Group Description	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
Measure Participants	134	266	733	728
Baseline	7.7 (0.55)	7.7 (0.54)	7.7 (0.57)	7.7 (0.58)
Week 26	8.0 (0.86)	7.3 (0.94)	7.1 (0.83)	7.2 (0.90)

2. Primary Outcome

Title	Change in Hemoglobin A1c From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Description	Percent change in hemoglobin (HbA1c) levels are reported. Greater (negative) percent change indicates improvement.
Time Frame	Baseline up to 26 weeks post-dose

Outcome Measure Data

Analysis Population Description

Change in hemoglobin A1c (HbA1c) levels were assessed using the Full Analysis Set.

Arm/Group Title	Placebo	Rivoglitazone 1.0 mg	Rivoglitazone 1.5mg	Pioglitazone 45 mg
Arm/Group Description	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
Measure Participants	134	266	733	728
Mean (Standard Deviation) [percent change in HbA1c]	0.3 (0.69)	-0.3 (0.75)	-0.6 (0.72)	-0.5 (0.77)

3. Secondary Outcome

Title	Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Description	Normal fasting plasma glucose (FPG) levels are being reported. Normal FPG levels range from 70-110 mg/dL. Lower FPG values indicates better clinical outcome, ie. improvement in FPG.
Time Frame	Baseline up to week 26 post-dose

Outcome Measure Data

Analysis Population Description

Fasting plasma glucose levels were assessed in participants with available data in the Full Analysis Set.

Arm/Group Title	Placebo	Rivoglitazone 1.0 mg	Rivoglitazone 1.5mg	Pioglitazone 45 mg
Arm/Group Description	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
Measure Participants	133	263	729	721
Baseline	161.1 (44.28)	159.2 (42.33)	160.9 (40.24)	161.9 (42.96)
Week 26	167.5 (41.23)	136.5 (39.73)	128.6 (35.06)	132.3 (38.32)

4. Secondary Outcome

Title	Change in Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Description	The change in normal fasting plasma glucose (FPG) levels are being reported. A greater (negative) change from baseline indicates an improvement in FPG.
Time Frame	Baseline up to 26 weeks post-dose

Outcome Measure Data

Analysis Population Description

Change in fasting plasma glucose levels were assessed in participants with values at both baseline and study endpoint.

Arm/Group Title	Placebo	Rivoglitazone 1.0 mg	Rivoglitazone 1.5mg	Pioglitazone 45 mg
Arm/Group Description	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
Measure Participants	133	263	729	721
Mean (Standard Deviation) [mg/dL]	6.1 (39.61)	-22.1 (34.75)	-32.4 (38.48)	-29.5 (40.32)

5. Secondary Outcome

Title	Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Description	Homeostasis Model Assessment index for Insulin Resistance (HOMA-IR) was calculated as: (fasting insulin concentration [μU/mL] x fasting glucose concentration [mmol/L])/22.5 Low HOMA-IR scores indicate high insulin sensitivity, whereas high HOMA-IR scores indicate low insulin sensitivity (insulin resistance). A normal HOMA-IR score is <2.60, HOMA-IR scores 2.60-3.80 are considered "borderline high", and HOMA-IR scores >3.80 are considered "high" and have correlations of insulin resistance. High HOMA-IR scores indicate worse outcome.
Time Frame	Baseline up to week 26 post-dose

Outcome Measure Data

Analysis Population Description

Homeostasis Model Assessment Index was assessed in participants with available data in the Full Analysis Set.

Arm/Group Title	Placebo	Rivoglitazone 1.0 mg	Rivoglitazone 1.5mg	Pioglitazone 45 mg
Arm/Group Description	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
Measure Participants	104	243	690	671
Baseline	6.2 (6.98)	5.6 (4.64)	6.0 (6.65)	6.2 (6.92)
Week 26	6.8 (5.65)	4.0 (3.78)	3.7 (4.49)	4.1 (4.75)

6. Secondary Outcome

Title	Change in Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Description	The change in the Homeostasis Model Assessment index for Insulin Resistance (HOMA-IR) was calculated as: (fasting insulin concentration [μU/mL] x fasting glucose concentration [mmol/L])/22.5 Low HOMA-IR scores indicate high insulin sensitivity, whereas high HOMA-IR scores indicate low insulin sensitivity (insulin resistance). A normal HOMA-IR score is <2.60, HOMA-IR scores 2.60-3.80 are considered "borderline high", and HOMA-IR scores >3.80 are considered "high" and have correlations of insulin resistance. A negative HOMA-IR score indicates an improvement in insulin sensitivity.
Time Frame	Baseline up to 26 weeks post-dose

Outcome Measure Data

Analysis Population Description

Change in Homeostasis Model Assessment Index was assessed in participants with values for baseline and study endpoint.

Arm/Group Title	Placebo	Rivoglitazone 1.0 mg	Rivoglitazone 1.5mg	Pioglitazone 45 mg
Arm/Group Description	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
Measure Participants	104	243	690	671
Mean (Standard Deviation) [score on a scale]	0.4 (7.56)	-1.5 (3.79)	-2.3 (5.15)	-2.2 (7.56)

7. Secondary Outcome

Title	Total Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Description	Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol.
Time Frame	Baseline up to week 26 post-dose

Outcome Measure Data

Analysis Population Description

Total cholesterol levels were assessed in participants with available data in the Full Analysis Set.

Arm/Group Title	Placebo	Rivoglitazone 1.0 mg	Rivoglitazone 1.5mg	Pioglitazone 45 mg
Arm/Group Description	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
Measure Participants	106	246	694	678
Baseline	190.1 (36.23)	193.4 (38.27)	191.6 (38.80)	189.8 (39.42)
Week 26	191.9 (39.60)	198.0 (40.39)	199.1 (43.14)	194.6 (41.84)

8. Secondary Outcome

Title	Percent Change in Total Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Description	Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol. Higher percent change in total cholesterol indicates better outcome, ie. improvement.
Time Frame	Baseline up to 26 weeks post-dose

Outcome Measure Data

Analysis Population Description

Percent change in total cholesterol levels were assessed in participants with values at baseline and study endpoint.

Arm/Group Title	Placebo	Rivoglitazone 1.0 mg	Rivoglitazone 1.5mg	Pioglitazone 45 mg
Arm/Group Description	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
Measure Participants	106	246	694	678
Mean (Standard Deviation) [percent change in total cholesterol]	1.9 (13.01)	4.0 (17.81)	5.3 (17.49)	3.6 (16.31)

9. Secondary Outcome

Title	Total Triglycerides At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Description	Total Triglycerides (TG) is a measure of the total amount of triglycerides in the blood. The equation to calculate total triglycerides is: (total cholesterol-Low-density Lipoprotein cholesterol (LDL- C) - High-density lipoprotein cholesterol (HDL- C)) x 5 = Total Triglycerides. Normal triglyceride levels are below 150 mg/dL.
Time Frame	Baseline up to Week 26 post-dose

Outcome Measure Data

Analysis Population Description

Total triglyceride levels were assessed in participants with available data in the Full Analysis Set.

Arm/Group Title	Placebo	Rivoglitazone 1.0 mg	Rivoglitazone 1.5mg	Pioglitazone 45 mg
Arm/Group Description	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
Measure Participants	106	246	694	678
Baseline	185.6 (111.25)	173.3 (104.90)	169.5 (101.27)	175.0 (96.75)
Week 26	170.5 (99.17)	148.0 (91.88)	141.0 (84.12)	152.1 (112.72)

10. Secondary Outcome

Title	Percent Change in Total Triglycerides From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Description	Total Triglycerides (TG) is a measure of the total amount of triglycerides in the blood. The equation to calculate total triglycerides is: (total cholesterol-Low-density Lipoprotein cholesterol (LDL- C) - High-density lipoprotein cholesterol (HDL- C)) x 5 = Total Triglycerides. A negative change means better outcome, ie. improvement.
Time Frame	Baseline up to 26 weeks post-dose

Outcome Measure Data

Analysis Population Description

Percent change in total triglyceride levels were assessed in participants with values at baseline and study endpoint.

Arm/Group Title	Placebo	Rivoglitazone 1.0 mg	Rivoglitazone 1.5mg	Pioglitazone 45 mg
Arm/Group Description	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
Measure Participants	106	246	694	678
Mean (Standard Deviation) [percent change in total triglycerides]	-1.8 (26.52)	-10.3 (32.84)	-11.7 (34.35)	-9.6 (45.84)

11. Secondary Outcome

Title	Low-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Description	Low-density lipoprotein cholesterol (LDL-C), "bad" cholesterol, is a measure of the total amount of low-density lipoprotein cholesterol in the blood. Normal LDL levels are <100 mg/dL.
Time Frame	Baseline up to Week 26 post-dose

Outcome Measure Data

Analysis Population Description

Low-density lipoprotein cholesterol levels were assessed in participants with available data in the Full Analysis Set.

Arm/Group Title	Placebo	Rivoglitazone 1.0 mg	Rivoglitazone 1.5mg	Pioglitazone 45 mg
Arm/Group Description	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
Measure Participants	106	246	694	674
Baseline	108.5 (29.68)	112.8 (32.37)	112.1 (32.35)	110.5 (33.60)
Week 26	111.8 (31.37)	118.0 (34.19)	118.7 (36.99)	115.0 (36.03)

12. Secondary Outcome

Title	Percent Change in Low-Density Lipoprotein Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Description	Low-density lipoprotein cholesterol (LDL-C), "bad" cholesterol, is a measure of the total amount of low-density lipoprotein cholesterol in the blood. A higher percent change indicates improvement.
Time Frame	Baseline up to 26 weeks post-dose

Outcome Measure Data

Analysis Population Description

Percent change in low-density lipoprotein cholesterol was assessed in participants with values at baseline and study endpoint.

Arm/Group Title	Placebo	Rivoglitazone 1.0 mg	Rivoglitazone 1.5mg	Pioglitazone 45 mg
Arm/Group Description	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
Measure Participants	106	246	694	674
Mean (Standard Deviation) [percent change in LDL]	3.4 (18.56)	9.3 (32.91)	9.6 (30.02)	7.3 (32.25)

13. Secondary Outcome

Title	High-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Description	High-density lipoprotein cholesterol (HDL-C), "good" cholesterol, is a measure of the total amount of high-density lipoprotein cholesterol in the blood. Normal HDL levels are >40 mg/dL.
Time Frame	Baseline to Week 26 post-dose

Outcome Measure Data

Analysis Population Description

High-density lipoprotein cholesterol was assessed in participants with available data in the Full Analysis Set.

Arm/Group Title	Placebo	Rivoglitazone 1.0 mg	Rivoglitazone 1.5mg	Pioglitazone 45 mg
Arm/Group Description	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
Measure Participants	106	246	694	675
Baseline	45.3 (11.73)	46.0 (12.49)	45.8 (11.46)	44.7 (10.25)
Week 26	45.6 (11.46)	50.4 (14.84)	52.0 (14.72)	49.7 (12.65)

14. Secondary Outcome

Title	Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Description	High-density lipoprotein cholesterol (HDL-C), "good" cholesterol, is a measure of the total amount of high-density lipoprotein cholesterol in the blood. A higher percent change indicates improvement.
Time Frame	Baseline to 26 weeks post-dose

Outcome Measure Data

Analysis Population Description

Percent change in high-density lipoprotein cholesterol was assessed in participants with values at baseline and study endpoint.

Arm/Group Title	Placebo	Rivoglitazone 1.0 mg	Rivoglitazone 1.5mg	Pioglitazone 45 mg
Arm/Group Description	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
Measure Participants	106	246	694	675
Mean (Standard Deviation) [percent change]	2.7 (14.30)	10.3 (18.15)	14.8 (22.65)	12.3 (21.97)

15. Secondary Outcome

Title	Apolipoprotein A-I At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Description	Apolipoprotein (Apo) A-I levels, a measure of the total amount of Apolipoprotein (Apo) A-I in the blood, are being reported. Normal Apo A-1 levels range from 120-140 mg/dL.
Time Frame	Baseline to Week 26 post-dose

Outcome Measure Data

Analysis Population Description

Apolipoprotein A-I was assessed in participants with available data in the Full Analysis Set.

Arm/Group Title	Placebo	Rivoglitazone 1.0 mg	Rivoglitazone 1.5mg	Pioglitazone 45 mg
Arm/Group Description	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
Measure Participants	105	245	691	677
Baseline	145.3 (25.11)	145.7 (27.60)	145.2 (24.31)	143.6 (22.88)
Week 26	146.2 (26.39)	146.4 (29.52)	145.9 (27.37)	143.9 (24.97)

16. Secondary Outcome

Title	Percent Change in Apolipoprotein A-I From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Description	Apolipoprotein (Apo) A-I is a measure of the total amount of Apolipoprotein (Apo) A-I in the blood. Decreased ApoA-1 levels are associated with poor clinical outcome. A lower percent change in ApoA-1 levels indicates an improvement in clinical outcome.
Time Frame	Baseline up to 26 weeks post-dose

Outcome Measure Data

Analysis Population Description

Percent change in apolipoprotein A-I was assessed in participants with values at baseline and study endpoint.

Arm/Group Title	Placebo	Rivoglitazone 1.0 mg	Rivoglitazone 1.5mg	Pioglitazone 45 mg
Arm/Group Description	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
Measure Participants	105	245	691	677
Mean (Standard Deviation) [percent change]	2.0 (12.22)	1.0 (12.88)	0.9 (13.18)	0.8 (13.09)

17. Secondary Outcome

Title	Apolipoprotein B At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Description	Apolipoprotein (Apo) B, a measure of the total amount of Apo B in the blood, is being reported. Normal Apo B levels are <100 mg/dL.
Time Frame	Baseline to Week 26 post-dose

Outcome Measure Data

Analysis Population Description

Apolipoprotein B was assessed in participants with available data in the Full Analysis Set.

Arm/Group Title	Placebo	Rivoglitazone 1.0 mg	Rivoglitazone 1.5mg	Pioglitazone 45 mg
Arm/Group Description	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
Measure Participants	105	245	691	677
Baseline	112.8 (25.24)	116.1 (26.49)	114.6 (26.88)	114.3 (27.33)
Week 26	115.3 (26.50)	113.6 (28.60)	111.5 (30.29)	110.3 (28.90)

18. Secondary Outcome

Title	Percent Change in Apolipoprotein B From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Description	Apolipoprotein (Apo) B, a measure of the total amount of Apo B in the blood, is being reported. A greater (negative) percent change in ApoB levels indicated an improvement in clinical outcome.
Time Frame	Baseline up to 26 weeks post-dose

Outcome Measure Data

Analysis Population Description

Apolipoprotein B was assessed in participants with values at baseline and study endpoint.

Arm/Group Title	Placebo	Rivoglitazone 1.0 mg	Rivoglitazone 1.5mg	Pioglitazone 45 mg
Arm/Group Description	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
Measure Participants	105	245	691	677
Mean (Standard Deviation) [percent change]	3.0 (14.83)	-0.4 (19.46)	-1.1 (21.24)	-2.5 (18.17)

19. Secondary Outcome

Title	Hemoglobin A1c at Baseline and Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Description	Percentage of hemoglobin A1c (HbA1c) levels are reported.
Time Frame	Baseline up to Week 52 post-dose

Outcome Measure Data

Analysis Population Description

Hemoglobin A1c levels were assessed using the Study Extension Set.

Arm/Group Title	Rivoglitazone 1.0 mg	Rivoglitazone 1.5mg	Pioglitazone 45 mg	Placebo/Pioglitazone 45 mg
Arm/Group Description	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.
Measure Participants	66	200	194	27
Baseline	7.5 (0.46)	7.6 (0.53)	7.6 (0.51)	7.4 (0.48)
Week 52	7.0 (0.72)	6.9 (0.60)	6.9 (0.58)	7.0 (0.75)

20. Secondary Outcome

Title	Change in Hemoglobin A1c From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Description	Change in hemoglobin (HbA1c) levels are reported. Greater (negative) percent change indicates improvement.
Time Frame	Baseline up to 52 weeks post-dose

Outcome Measure Data

Analysis Population Description

Hemoglobin A1c was assessed in participants with values at baseline and the extension visit at the end of Cycle 1.

Arm/Group Title	Rivoglitazone 1.0 mg	Rivoglitazone 1.5mg	Pioglitazone 45 mg	Placebo/ Pioglitazone 45 mg
Arm/Group Description	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.
Measure Participants	27	65	54	11
Mean (Standard Deviation) [percent change in HbA1c]	-0.5 (0.69)	-0.7 (0.57)	-0.7 (0.67)	-0.4 (0.70)

21. Secondary Outcome

Title	Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Description	Normal fasting plasma glucose (FPG) levels are being reported. Normal FPG levels range from 70-110 mg/dL. Lower FPG values indicates better clinical outcome, ie. improvement in FPG.
Time Frame	Baseline up to Week 52 post-dose

Outcome Measure Data

Analysis Population Description

Fasting plasma glucose (FPG) levels were assessed in participants with available data in the Study Extension Set.

Arm/Group Title	Rivoglitazone 1.0 mg	Rivoglitazone 1.5mg	Pioglitazone 45 mg	Placebo/ Pioglitazone 45 mg
Arm/Group Description	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.
Measure Participants	64	200	193	27
Baseline	147.4 (32.31)	152.8 (32.32)	149.0 (36.00)	142.5 (27.81)
Week 52	117.8 (27.93)	116.6 (24.12)	115.6 (19.04)	124.9 (36.92)

22. Secondary Outcome

Title	Change in Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Description	The change in normal fasting plasma glucose (FPG) levels are being reported. A greater (negative) change from baseline indicates an improvement in FPG.
Time Frame	Baseline up to 52 weeks post-dose

Outcome Measure Data

Analysis Population Description

Fasting plasma glucose (FPG) was assessed in participants with values at baseline and the extension visit at the end of Cycle 1. Participants who did not have both baseline and Week 52 data were not included in this analysis (n=1 each for Rivoglitazone 1.0 mg and Pioglitazone 45 mg groups).

Arm/Group Title	Rivoglitazone 1.0 mg	Rivoglitazone 1.5mg	Pioglitazone 45 mg	Placebo/ Pioglitazone 45 mg
Arm/Group Description	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.
Measure Participants	20	48	37	7
Mean (Standard Deviation) [mg/dL]	-33.8 (41.48)	-34.2 (24.86)	-29.5 (31.39)	-35.9 (20.75)

23. Secondary Outcome

Title	Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Description	Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of double-blind study medication, and ongoing AEs that started prior to the first dose of double-blind study medication and increased in severity on or after the first dose of double-blind study medication.
Time Frame	Week -2 up to Week 52 post-dose

Outcome Measure Data

Analysis Population Description

Drug-related TEAEs were assessed in the Safety Set which included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement.

Arm/Group Title	Placebo	Rivoglitazone 1.0 mg	Rivoglitazone 1.5mg	Pioglitazone 45 mg
Arm/Group Description	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.	Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
Measure Participants	137	269	741	739
Participants with drug-related TEAEs	15 10.9%	50 18.2%	144 19.2%	134 17.8%
Gastritis	1 0.7%	3 1.1%	2 0.3%	7 0.9%
Edema	0 0%	2 0.7%	5 0.7%	9 1.2%
Edema peripheral	1 0.7%	14 5.1%	46 6.1%	46 6.1%
Pitting edema	0 0%	6 2.2%	10 1.3%	13 1.7%
Weight increased	0 0%	5 1.8%	23 3.1%	12 1.6%
Fluid retention	0 0%	3 1.1%	2 0.3%	1 0.1%

Adverse Events

Time Frame	Treatment-emergent adverse events (TEAEs) data were assessed from the signing of the informed consent (Week -2) up to 52 weeks post-dose for the duration of the study period.
Adverse Event Reporting Description	Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of double-blind (DB) study medication, and ongoing AEs that started prior to the first dose of DB study medication and increased in severity on or after the first dose of DB study medication. TEAEs were reported from the Safety Set which included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement.
Arm/Group Title	Placebo		Rivoglitazone 1.0 mg		Rivoglitazone 1.5mg		Pioglitazone 45 mg
Arm/Group Description	Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo over-encapsulated tablet once daily for 26 weeks.		Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0 mg tablet once daily for 26 weeks.		Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5 mg tablet once daily for 26 weeks.		Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg over-encapsulated tablet once daily for 26 weeks.
All Cause Mortality
	Placebo		Rivoglitazone 1.0 mg		Rivoglitazone 1.5mg		Pioglitazone 45 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/137 (0%)		0/269 (0%)		0/741 (0%)		2/739 (0.3%)
Serious Adverse Events
	Placebo		Rivoglitazone 1.0 mg		Rivoglitazone 1.5mg		Pioglitazone 45 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/137 (2.2%)		10/269 (3.7%)		22/741 (3%)		28/739 (3.8%)
Blood and lymphatic system disorders
Anemia	0/137 (0%)		0/269 (0%)		1/741 (0.1%)		0/739 (0%)
Cardiac disorders
Angina unstable	0/137 (0%)		0/269 (0%)		1/741 (0.1%)		0/739 (0%)
Atrioventricular block	0/137 (0%)		0/269 (0%)		1/741 (0.1%)		0/739 (0%)
Cardiac failure	0/137 (0%)		0/269 (0%)		1/741 (0.1%)		0/739 (0%)
Cardiac failure congestive	0/137 (0%)		1/269 (0.4%)		1/741 (0.1%)		3/739 (0.4%)
Coronary artery disease	0/137 (0%)		0/269 (0%)		0/741 (0%)		2/739 (0.3%)
Myocardial infarction	0/137 (0%)		0/269 (0%)		0/741 (0%)		2/739 (0.3%)
Endocrine disorders
Basedow's disease	0/137 (0%)		0/269 (0%)		1/741 (0.1%)		0/739 (0%)
Eye disorders
Cataract	0/137 (0%)		0/269 (0%)		0/741 (0%)		1/739 (0.1%)
Gastrointestinal disorders
Ascites	0/137 (0%)		0/269 (0%)		0/741 (0%)		1/739 (0.1%)
Diarrhea	0/137 (0%)		0/269 (0%)		1/741 (0.1%)		0/739 (0%)
Gastritis	1/137 (0.7%)		0/269 (0%)		0/741 (0%)		1/739 (0.1%)
Gastroesophageal reflux disease	0/137 (0%)		0/269 (0%)		0/741 (0%)		1/739 (0.1%)
Umbilical hernia	0/137 (0%)		1/269 (0.4%)		0/741 (0%)		0/739 (0%)
Umbilical hernia, obstructive	0/137 (0%)		0/269 (0%)		0/741 (0%)		1/739 (0.1%)
General disorders
Hernia obstructive	0/137 (0%)		0/269 (0%)		1/741 (0.1%)		0/739 (0%)
Non-cardiac chest pain	1/137 (0.7%)		0/269 (0%)		1/741 (0.1%)		0/739 (0%)
Hepatobiliary disorders
Bile duct obstruction	0/137 (0%)		0/269 (0%)		0/741 (0%)		1/739 (0.1%)
Cholecystitis acute	0/137 (0%)		1/269 (0.4%)		0/741 (0%)		0/739 (0%)
Cholelithiasis	0/137 (0%)		0/269 (0%)		0/741 (0%)		1/739 (0.1%)
Hepatitis acute	0/137 (0%)		0/269 (0%)		0/741 (0%)		1/739 (0.1%)
Infections and infestations
Appendicitis	0/137 (0%)		0/269 (0%)		1/741 (0.1%)		0/739 (0%)
Cystitis	0/137 (0%)		0/269 (0%)		1/741 (0.1%)		0/739 (0%)
Dengue fever	0/137 (0%)		0/269 (0%)		0/741 (0%)		1/739 (0.1%)
Enterocolitis infectious	0/137 (0%)		0/269 (0%)		0/741 (0%)		1/739 (0.1%)
Gastroenteritis	0/137 (0%)		0/269 (0%)		1/741 (0.1%)		0/739 (0%)
Hepatitis A	0/137 (0%)		0/269 (0%)		0/741 (0%)		1/739 (0.1%)
Pneumonia	0/137 (0%)		0/269 (0%)		0/741 (0%)		1/739 (0.1%)
Urinary tract infection	0/137 (0%)		0/269 (0%)		1/741 (0.1%)		1/739 (0.1%)
Injury, poisoning and procedural complications
Alcohol poisoning	0/137 (0%)		1/269 (0.4%)		0/741 (0%)		0/739 (0%)
Ankle fracture	0/137 (0%)		0/269 (0%)		0/741 (0%)		1/739 (0.1%)
Concussion	0/137 (0%)		1/269 (0.4%)		0/741 (0%)		0/739 (0%)
Facial bones fracture	0/137 (0%)		0/269 (0%)		0/741 (0%)		1/739 (0.1%)
Hand fracture	1/137 (0.7%)		0/269 (0%)		0/741 (0%)		0/739 (0%)
Lower limb fracture	0/137 (0%)		0/269 (0%)		1/741 (0.1%)		0/739 (0%)
Road traffic accident	0/137 (0%)		1/269 (0.4%)		0/741 (0%)		1/739 (0.1%)
Spinal compression	0/137 (0%)		0/269 (0%)		1/741 (0.1%)		0/739 (0%)
Traumatic brain injury	0/137 (0%)		0/269 (0%)		0/741 (0%)		1/739 (0.1%)
Metabolism and nutrition disorders
Hypoglycemia	1/137 (0.7%)		0/269 (0%)		0/741 (0%)		0/739 (0%)
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder	0/137 (0%)		1/269 (0.4%)		0/741 (0%)		0/739 (0%)
Intervertebral disc protrusion	0/137 (0%)		0/269 (0%)		0/741 (0%)		1/739 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas	0/137 (0%)		0/269 (0%)		0/741 (0%)		1/739 (0.1%)
Bladder neoplasm	0/137 (0%)		0/269 (0%)		1/741 (0.1%)		0/739 (0%)
Chronic lymphocytic leukemia	0/137 (0%)		0/269 (0%)		1/741 (0.1%)		0/739 (0%)
Colon cancer	0/137 (0%)		1/269 (0.4%)		0/741 (0%)		0/739 (0%)
Endometrial cancer	0/137 (0%)		1/269 (0.4%)		0/741 (0%)		0/739 (0%)
Gastric cancer	0/137 (0%)		1/269 (0.4%)		0/741 (0%)		0/739 (0%)
Metastasis	0/137 (0%)		1/269 (0.4%)		0/741 (0%)		0/739 (0%)
Pancreatic carcinoma	0/137 (0%)		0/269 (0%)		0/741 (0%)		2/739 (0.3%)
Thyroid neoplasm	0/137 (0%)		0/269 (0%)		1/741 (0.1%)		0/739 (0%)
Nervous system disorders
Cerebral ischemia	0/137 (0%)		0/269 (0%)		0/741 (0%)		1/739 (0.1%)
Cerebrovascular accident	0/137 (0%)		0/269 (0%)		1/741 (0.1%)		1/739 (0.1%)
Ischemic stroke	0/137 (0%)		0/269 (0%)		0/741 (0%)		1/739 (0.1%)
Status migrainous	0/137 (0%)		0/269 (0%)		1/741 (0.1%)		0/739 (0%)
Syncope	0/137 (0%)		1/269 (0.4%)		0/741 (0%)		0/739 (0%)
Psychiatric disorders
Schizoaffective disorder	0/137 (0%)		0/269 (0%)		1/741 (0.1%)		0/739 (0%)
Suicide attempt	0/137 (0%)		0/269 (0%)		0/741 (0%)		1/739 (0.1%)
Renal and urinary disorders
Nephrolithiasis	0/137 (0%)		0/269 (0%)		1/741 (0.1%)		0/739 (0%)
Renal colic	0/137 (0%)		0/269 (0%)		2/741 (0.3%)		0/739 (0%)
Renal failure acute	0/137 (0%)		0/269 (0%)		1/741 (0.1%)		0/739 (0%)
Reproductive system and breast disorders
Polycystic ovaries	0/137 (0%)		0/269 (0%)		1/741 (0.1%)		0/739 (0%)
Uterine polyp	0/137 (0%)		0/269 (0%)		1/741 (0.1%)		0/739 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	0/137 (0%)		0/269 (0%)		2/741 (0.3%)		0/739 (0%)
Pulmonary embolism	0/137 (0%)		0/269 (0%)		0/741 (0%)		1/739 (0.1%)
Pulmonary thrombosis	0/137 (0%)		0/269 (0%)		0/741 (0%)		1/739 (0.1%)
Vascular disorders
Hypertension	0/137 (0%)		0/269 (0%)		0/741 (0%)		1/739 (0.1%)
Varicose vein	0/137 (0%)		0/269 (0%)		0/741 (0%)		1/739 (0.1%)
Venous thrombosis limb	0/137 (0%)		0/269 (0%)		2/741 (0.3%)		0/739 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Rivoglitazone 1.0 mg		Rivoglitazone 1.5mg		Pioglitazone 45 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	56/137 (40.9%)		131/269 (48.7%)		408/741 (55.1%)		374/739 (50.6%)
Gastrointestinal disorders
Diarrhea	2/137 (1.5%)		1/269 (0.4%)		14/741 (1.9%)		17/739 (2.3%)
Gastritis	3/137 (2.2%)		5/269 (1.9%)		10/741 (1.3%)		9/739 (1.2%)
Influenza	3/137 (2.2%)		5/269 (1.9%)		15/741 (2%)		17/739 (2.3%)
General disorders
Edema peripheral	3/137 (2.2%)		18/269 (6.7%)		54/741 (7.3%)		56/739 (7.6%)
Pitting edema	0/137 (0%)		7/269 (2.6%)		10/741 (1.3%)		17/739 (2.3%)
Infections and infestations
Bronchitis	4/137 (2.9%)		5/269 (1.9%)		24/741 (3.2%)		20/739 (2.7%)
Gastroenteritis	1/137 (0.7%)		4/269 (1.5%)		15/741 (2%)		7/739 (0.9%)
Nasopharyngitis	6/137 (4.4%)		13/269 (4.8%)		40/741 (5.4%)		41/739 (5.5%)
Upper respiratory tract infection	3/137 (2.2%)		8/269 (3%)		38/741 (5.1%)		25/739 (3.4%)
Urinary tract infection	6/137 (4.4%)		19/269 (7.1%)		34/741 (4.6%)		30/739 (4.1%)
Investigations
Weight increased	0/137 (0%)		5/269 (1.9%)		24/741 (3.2%)		14/739 (1.9%)
Metabolism and nutrition disorders
Hypoglycemia	3/137 (2.2%)		1/269 (0.4%)		7/741 (0.9%)		3/739 (0.4%)
Musculoskeletal and connective tissue disorders
Arthralgia	3/137 (2.2%)		7/269 (2.6%)		24/741 (3.2%)		14/739 (1.9%)
Back pain	2/137 (1.5%)		6/269 (2.2%)		19/741 (2.6%)		22/739 (3%)
Pain in extremity	5/137 (3.6%)		4/269 (1.5%)		13/741 (1.8%)		20/739 (2.7%)
Nervous system disorders
Dizziness	1/137 (0.7%)		4/269 (1.5%)		15/741 (2%)		7/739 (0.9%)
Headache	5/137 (3.6%)		7/269 (2.6%)		27/741 (3.6%)		27/739 (3.7%)
Respiratory, thoracic and mediastinal disorders
Cough	2/137 (1.5%)		8/269 (3%)		7/741 (0.9%)		10/739 (1.4%)
Vascular disorders
Hypertension	4/137 (2.9%)		4/269 (1.5%)		18/741 (2.4%)		18/739 (2.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.